Janssen Seeks European Approval of Extended Indication for Rybrevant
Artur - stock.adobe.com
The Janssen Pharmaceutical Companies of Johnson & Johnson have requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab). The submission was announced in an Oct. 6, 2023 company press release.
In the Type II extension request, submitted to the European Medicines Agency (EMA), Janssen is seeking approval for its amivantamab therapy to be used in combination with chemotherapy (carboplatin and pemetrexed) as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Janssens’ antibody therapy was granted conditional marketing authorization by the European Commission in December 2021 as a monotherapy for adults with NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy has been unsuccessful.
The indication extension application to EMA is supported by the results of a Phase III clinical study (PAPILLON) that has evaluated the efficacy and safety of amivantamab in combination with chemotherapy as a first line treatment for NSCLC patients with EGFR exon 20 insertion mutations. In July 2023, Janssen revealed that the Phase III study met its primary endpoint, demonstrating that the combination of amivantamab with chemotherapy provided a statistically significant and clinically meaningful improvement in progression-free survival for patients when compared with chemotherapy alone.
“People living with advanced or metastatic NSCLC with activating EGFR exon 20 insertion mutations generally face a poor survival probability, and new treatment options are urgently needed from the very first line of therapy,” said Martin Vogel, EMEA Therapeutic Area Lead Oncology, Janssen-Cilag, in the press release. “Today’s submission to the EMA highlights our deep commitment to change the trajectory of lung cancer, through earlier intervention with targeted treatment options for eligible patients.”
“PAPILLON is the first randomised Phase [III] study to read out in patients with NSCLC with EGFR exon 20 insertion mutations. Pending approval, this creates an opportunity to make a significant improvement to the standard of care for this patient population, where high unmet medical needs remain,” added Kiran Patel, vice president, Clinical Development, Solid Tumors, Janssen Research & Development, in the press release. “We look forward to working with the EMA to bring this potential new indication to the lung cancer community as soon as possible.”
Source: Janssen
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
